Back to resultsA Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
folic acid
methotrexate
tocilizumab [RoActemra/Actemra]
tocilizumab [RoActemra/Actemra]
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- adults 18 - 75 years of age
- active rheumatoid arthritis of >/= 6 months duration
- inadequate response to at least 12 weeks of methotrexate, the last 8 prior to baseline on stable dose
- swollen joint count (SJC)>/=4, tender joint count (TJC)>/=6 at screening and baseline
- DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline
- oral corticosteroids (</= 10mg/day prednisone or equivalent) and NSAIDS on stable dose </= 4 weeks prior to baseline
Exclusion Criteria:
- rheumatic autoimmune disease other than rheumatoid arthritis
- prior history or current inflammatory joint disease other than rheumatoid arthritis
- major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- functional class IV by ACR classification
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Pharmacokinetics of TCZ after QW or Q2W sc administration
Pharmacodynamic responses of CRP
Safety and tolerability, including injection site reaction
Secondary Outcome Measures
Efficacy according to ACR and DAS-EULAR parameters
PD responses of IL-6, sIL-6R and anti TCZ antibody
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00965653
Brief Title
A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis
Official Title
Open-label, Multicenter, Randomized, Parallel Study to Investigate pk, pd, Efficacy and Safety of Tocilizumab (TCZ, RO4877533) Following Subcutaneous Administration of TCZ 162 mg Weekly or Every Other Week in Combination With Methotrexate in Patients With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2011 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This open-label randomized 2arm study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals during treatment and on the 3 weeks of follow-up.Target sample size is < 50 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
folic acid
Intervention Description
>/= 5 mg po weekly
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Description
7.5 - 25 mg weekly (oral or parenteral)
Intervention Type
Drug
Intervention Name(s)
tocilizumab [RoActemra/Actemra]
Intervention Description
162 mg sc weekly (QW)for 12 weeks
Intervention Type
Drug
Intervention Name(s)
tocilizumab [RoActemra/Actemra]
Intervention Description
162 mg sc every other week (Q2W) for 12 weeks
Primary Outcome Measure Information:
Title
Pharmacokinetics of TCZ after QW or Q2W sc administration
Time Frame
multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up
Title
Pharmacodynamic responses of CRP
Time Frame
sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment
Title
Safety and tolerability, including injection site reaction
Time Frame
laboratory assessments every 2nd week on treatment and after 3 weeks follow-up, injection site evaluation after 1st, 2nd and last injection.
Secondary Outcome Measure Information:
Title
Efficacy according to ACR and DAS-EULAR parameters
Time Frame
assessments on day 1 of weeks 1, 4, 8 and 12
Title
PD responses of IL-6, sIL-6R and anti TCZ antibody
Time Frame
multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults 18 - 75 years of age
active rheumatoid arthritis of >/= 6 months duration
inadequate response to at least 12 weeks of methotrexate, the last 8 prior to baseline on stable dose
swollen joint count (SJC)>/=4, tender joint count (TJC)>/=6 at screening and baseline
DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline
oral corticosteroids (</= 10mg/day prednisone or equivalent) and NSAIDS on stable dose </= 4 weeks prior to baseline
Exclusion Criteria:
rheumatic autoimmune disease other than rheumatoid arthritis
prior history or current inflammatory joint disease other than rheumatoid arthritis
major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
functional class IV by ACR classification
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
St John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 5E8
Country
Canada
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M 5N6
Country
Canada
City
Trois-rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
City
La Coruna
State/Province
La Coruña
ZIP/Postal Code
15006
Country
Spain
City
Santiago de Compostela
State/Province
La Coruña
ZIP/Postal Code
15706
Country
Spain
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis
We'll reach out to this number within 24 hrs